NeuralgiaEarly Phase 1BTXADMPPNPNCT02460107
Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy
A Early Phase 1 study testing Botulinum toxin type A and Normal saline in people with Neuralgia, run by Catholic University of Korea Saint Paul's Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether botulinum toxin A is effective in the treatment of neuropathic pain in patients with diabetic peripheral polyneuropathy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neuralgia
- What is being tested?
- Botulinum toxin type A and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to 31 Dec 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • more than twenty years of age
- patients should have 4 or more items positive among the 10 items of the DN4 questionnaire.
- persistence of neuropathic pain for more than three months or remission and recurrence of neuropathic pain for more than six months
- a pain score of 4 or more on the numeric rating scale
Who cannot join
- • neuropathic pain caused by confounding factors other than diabetic neuropathic pain
- contraindicated for botulinum toxin type A
- a change in pain medication one month prior to study enrollment
- a condition involving neuromuscular junction (Ex. Eaton Lambert disease, myasthenia gravis)
- person who received botulinum toxin type A within three months prior to study enrollment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
St. Paul's Hospital, The Catholic University of Korea
Seoul
About this study
The purpose of this study is to determine whether botulinum toxin A is effective in the treatment of neuropathic pain in patients with diabetic peripheral polyneuropathy.
- Conditions
- Neuralgia
- Being tested
- Botulinum toxin type A, Normal saline
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ABiological
Normal salineOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Placebo comparator | Normal saline Receives: Other: Normal saline |
| Botulinum toxin type A 50U | Active comparator | Botulinum toxin 50U Receives: Biological: Botulinum toxin type A |
| Botulinum toxin type A 100U | Active comparator | Botulinum toxin 100U Receives: Biological: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity using numeric rating scale
Measured: 4 weeks after intervention
Secondary outcomes (2)
Pain intensity using numeric rating scale
Measured: 1, 8, 12, 24 weeks after intervention
Quality of life using WHOQOL
Measured: 4,8,12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMay 2015
- Primary completion30 Nov 2016
- Study completion31 Dec 2016
Why it stopped: Enrolling failure (lack of participants)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of Korea Saint Paul's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medy-Tox
- Responsible party
- Principal investigator, Myung Eun Chung, MD, PhD, Catholic University of Korea Saint Paul's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460107
- Sponsor's protocol ID
- CatholicUKSPH
- Acronym
- BTXADMPPNP
- Status last verified
- Aug 2017
- First submitted
- 29 May 2015
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy
- ClinicalTrials.gov ID
- NCT02460107
- Acronym / sponsor ID
- BTXADMPPNP / CatholicUKSPH
- Conditions
- Neuralgia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolling failure (lack of participants)
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Catholic University of Korea Saint Paul's HospitalUniversity, hospital or other
- Collaborators
- Medy-Tox
- Study start
- May 2015
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether botulinum toxin A is effective in the treatment of neuropathic pain in patients with diabetic peripheral polyneuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Placebo comparator | Other: Normal salineNormal saline |
| Botulinum toxin type A 50U | Active comparator | Biological: Botulinum toxin type ABotulinum toxin 50U |
| Botulinum toxin type A 100U | Active comparator | Biological: Botulinum toxin type ABotulinum toxin 100U |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • more than twenty years of age
Key exclusion criteria (5 listed)
- • neuropathic pain caused by confounding factors other than diabetic neuropathic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type A | Biological | Botulinum toxin type A 100U, Botulinum toxin type A 50U |
| Normal salinePlacebo | Other | Normal saline |
Primary outcome
Pain intensity using numeric rating scale
Time frame: 4 weeks after intervention
2 secondary outcomes
Pain intensity using numeric rating scale
Time frame: 1, 8, 12, 24 weeks after intervention
Quality of life using WHOQOL
Time frame: 4,8,12 weeks after intervention
Results and safety
The study was stopped early (reason given: Enrolling failure (lack of participants)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Botulinum toxin type A and Normal saline in people with Neuralgia, run by Catholic University of Korea Saint Paul's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrolling failure (lack of participants)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity using numeric rating scale (time frame: 4 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.